Low profile sterrable soft-tip catheter

• US 4,960,411 A
• Filed: 06/30/1988
• Issued: 10/02/1990
• Est. Priority Date: 09/18/1984
• Status: Expired due to Fees

• Current Assignee: Dianne M.F. Plunkett
• Original Assignee: Medtronic Versaflex Incorporated
• Inventors: Buchbinder, Maurice
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/213,662
• Time in Patent Office: 824 Days
• Field of Search: 604/95, 604/280, 604/264, 128/657, 128/772
• US Class Current: 604/95.01
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

Abstract

This invention relates to steerable catheters. More particularly, this invention relates to a steerable catheter comprising a flexible catheter member having distal and proximal ends and one or more lumens, the single lumen or one of the lumens being closed at its distal end, the one or more other lumens being open, for introduction of a central guide wire or other desired object; a deflection wire having distal and proximal ends and axially extending the length of the catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in the closed end; and control means attached to the proximal end of the catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages the deflection wire.

Claims

1. A steerable catheter means comprising:

an outer catheter shaft,

a flexible catheter member located within said outer catheter shaft having distal and proximal ends and one or more lumens extending therethrough, at least one of said lumens being closed at its distal end, the other lumen or lumens being open at the distal end or ends thereof,

a deflection were having distal and proximal ends and axially extending through a lumen having a closed end, the distal end of said deflection wire being embedded in said closed end, and

control means attached to the proximal end of said catheter member, the proximal end of said deflection wire extending through said control means and said control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing said deflection wire to longitudinally displace either toward or away from the distal end thereof, said displacement causing the distal end of said catheter member to bend out of or toward the line of he longitudinal axis of said catheter member, and the engaging means of said control means fixedly engaging said deflection wire so that when said control means is rotated, said catheter member and said deflection wire both rotate together to cause the distal end of said catheter member to rotate about its longitudinal axis.

2. A steerable catheter means consisting essentially of:

an outer catheter shaft,

a flexible catheter member located within said outer catheter shaft having distal and proximal ends and one or more lumens extending therethrough, at least one of said lumens being closed at its distal end, the other lumen or lumens being open at the distal end or ends thereof,

a deflection wire having distal and proximal ends and axially extending through a lumen having a closed end, the distal end of said deflection wire being embedded in said closed end, and

control means attached to the proximal end of said catheter member, the proximal end of said defection wire extending to said control means, said control means having engaging means which fixedly engages the proximal end of said deflection wire to cause said deflection wire to be displaced distally or proximally, said displacement causing the distal end of said catheter member to bend out of or toward the line of the longitudinal axis of said catheter member, and said control means having rotation means to cause said deflection wire and said catheter member to rotate together to cause the distal end of said catheter member to rotate about its longitudinal axis.

3. The steerable catheter means of claim 2, wherein said catheter comprises from 1 to 3 lumens.

4. The steerable catheter means of claim 2, wherein said catheter member has at least two lumens and one of said lumens is open.

5. The steerable catheter means of claim 4, wherein the open lumen is capable of having a balloon dilatation catheter or a retractable pressure sensor threaded therethrough.

6. The steerable catheter means of claim 2, wherein the outer surface of said catheter member near the distal portion thereof comprises dilatation balloon means.

7. The steerable catheter means of claim 6, wherein a closed lumen has openings near its distal end and said openings are arranged to permit inflation of said dilatation balloon means.

8. The steerable catheter means of claim 2, wherein a closed lumen has a pressure sensing fiber therein, said pressure sensing fiber having distal and proximal ends, the distal end of said pressure sensing fiber comprising a pressure sensing membrane, and the distal end of said pressure sensing fiber extending through the distal end of said catheter member whereby the pressure sensing membrane is substantially flush with the outer surface of the distal end of said catheter member.

9. The steerable catheter means of claim 2, wherein a flexible tip has proximal and distal ends and the proximal end thereof is affixed or embedded in the distal end of the catheter member.

10. The steerable catheter means of claim 9, wherein the flexible tip is a floppy wire comprised of spring steel wire.

11. The steerable catheter means of claim 2, wherein said catheter member comprises a lumen open at its distal end and the proximal end of said lumen is in fluid communication with a passageway in said control means.

12. A steerable catheter means consisting essentially of:

an outer catheter shaft,

a flexible catheter located within said outer catheter shaft having distal and proximal ends and two lumens extending therethrough, one of said lumens being closed at its distal end, and the other lumen being open at its distal end,

a deflection wire having distal and proximal ends and axially extending through the lumen having the closed end, the distal end of said deflection wire being embedded in said closed end, and

control means attached to the proximal end of said catheter means, the proximal end of said deflection wire extending to said control means, said control means having engaging means which fixedly engages the proximal end of said deflection wire to cause said deflection wire to be displaced distally or proximally, said displacement causing the distal end of said catheter member to bend out of or toward the line of the longitudinal axis of said catheter member, and said control means having rotation means to cause said deflection wire and said catheter member to rotate together to cause the distal end of said catheter member to rotate about its longitudinal axis.

13. A steerable catheter means consisting essentially of:

an outer catheter shaft,

a flexible catheter movably located within said outer catheter shaft having distal and proximal ends and one or more lumens extending therethrough, each of said lumens being closed at its distal end,

a deflection wire having distal and proximal end s and axially extending through the lumen having a closed end, the distal end of the deflection wire being embedded in said closed end, and

control means attached to the proximal end of said catheter member, the proximal end of said deflection wire extending to said control means, said control means having engaging means which fixedly engages the proximal end of said deflection wire to cause said deflection wire to be displaced distally or proximally, said displacement causing the distal end of said catheter member to bend out of or toward the line of the longitudinal axis of said catheter member, and said control means having rotation means to cause said deflection wire and said catheter member to rotate together to cause the distal end of said catheter member to rotate about its longitudinal axis.

14. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two or more lumens extending therethrough, one of said lumens being closed at its distal end, the one or more other lumens being open distally, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the wire being embedded in said closed end, and

control means attached to the proximal end of the inner catheter member, the proximal end of the deflection wire extending to the control means, the control means having engaging means which fixedly engages the proximal end of said deflection wire to cause said deflection wire to be displaced distally or proximally, said displacement causing the distal end of the inner catheter member to bend out of or toward the line of its longitudinal axis, the control means having a passageway in fluid connection with at least one open lumen, and the control means having rotation means to cause said deflection wire and the inner catheter member to rotate together to cause the distal end of the inner catheter member to rotate about its longitudinal axis.

15. The catheter means of claim 14 which also comprises a guide wire extending through an open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

16. The catheter means of claim 14 which also comprises a balloon dilatation catheter extending through an open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

17. The catheter means of claim 16, wherein the balloon dilatation catheter has a guiding lumen therein and a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protruding distally beyond the distal end of the inner catheter member, and the distal end of the guide wire extending distally beyond the distal end of the balloon dilatation catheter.

18. The catheter means of claim 14, wherein the inner catheter member has two lumens.

19. The catheter means of claim 14 which comprises balloon dilatation means arranged on the outer surface of the inner catheter member adjacent its distal end.

20. The catheter means of claim 14, wherein the inner catheter member is freely movable within the outer catheter shell.

21. The catheter means of claim 14, wherein the deflection wire is tapered at its distal end.

22. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two or more lumens extending therethrough, one of said lumens being closed at its distal end, the one or more other lumens being open distally, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having said closed end, the distal end of the wire being embedded in said closed end, and

control means attached to the proximal ends of the outer catheter member and the inner catheter member, the proximal end of the deflection wire extending to the control means, the control means having engaging means which fixedly engages the proximal end of said deflection wire to cause said deflection wire to be displaced distally or proximally, said displacement causing the distal end of the inner catheter member to bend out of or toward the line of its longitudinal axis, the control means having a passageway in fluid communication with at least one open lumen, and the control means having rotation means to cause said deflection wire and the inner catheter member to rotate substantially together to cause the distal end of the inner catheter member to rotate about its longitudinal axis.

23. The catheter means of claim 22 which also comprises a guide wire extending through an open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

24. The catheter means of claim 22 which also comprises a balloon dilatation catheter extending through an open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

25. The catheter means of claim 24, wherein the balloon dilatation catheter has a guiding lumen therein and a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protruding distally beyond the distal end of the inner catheter member, and the distal end of the guide wire extending distally beyond the distal end of the balloon dilatation catheter.

26. The catheter means of claim 22, wherein the inner catheter member has two lumens.

27. The catheter means of claim 22 which comprises balloon dilatation means arranged on the outer surfaces of the outer catheter member and the inner catheter member adjacent the distal end thereof.

28. The catheter means of claim 22 which comprises balloon dilatation means arranged on the outer surface of the distal end of the inner catheter member adjacent its distal end.

29. The catheter means of claim 22, wherein the deflection wire is tapered at its distal end.

30. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two or more lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen or lumens being open at the distal end or ends thereof, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal ends of the outer catheter member and the inner catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen or lumens, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the deflection wire both rotate together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

a balloon dilatation catheter extending through an open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent to said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

31. The catheter means of claim 30 which also comprises a guide wire extending through an open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

32. The catheter means of claim 30, wherein the balloon dilatation catheter has a guiding lumen therein, a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protrudes distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extends proximally beyond the proximal end of the balloon dilatation catheter.

33. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two or more lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen or lumens being open at the distal end or ends thereof, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal end of the outer catheter member and the inner catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen or lumens, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the deflection wire both rotate together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

balloon dilatation means arranged on the outer surface of the distal ends of the outer catheter member and the inner catheter member.

34. The catheter means of claim 33 which also comprises a guide wire extending through an open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

35. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two or more lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen or lumens being open at the distal end or ends thereof, the inner catheter member extending through the outer catheter shell, the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member, and the inner catheter member being movable within the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal end of the inner catheter member, the proximal end of the deflection wire extending through the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen or lumens, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the deflection wire both rotate together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

a balloon dilatation catheter extending through an open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent to said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

36. The catheter means of claim 35, wherein the balloon dilatation catheter has a guiding lumen therein, a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protrudes distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extends proximally beyond the proximal end of the balloon dilatation catheter.

37. The catheter means of claim 35 which also comprises a guide wire extending through an open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

38. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen being open at its distal end, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal ends of the outer catheter member and the inner catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the deflection wire both rotate substantially together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

a balloon dilatation catheter extending through the open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent to said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

39. The catheter means of claim 38, wherein the balloon dilatation catheter has a guiding lumen therein, a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protrudes distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extends proximally beyond the proximal end of the balloon dilatation catheter.

40. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen being open at its distal end, the inner catheter member extending through the outer catheter member, and the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal ends of the outer catheter member and the inner catheter member, the proximal end of the deflection wire extending to the control/means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the deflection wire both rotate substantially together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

balloon dilatation means arranged on the outer surfaces of the distal ends of the outer catheter member and the inner catheter member.

41. The catheter means of claim 40 which also comprises a guide wire extending through the open lumen, the guide wire having distal and proximal ends, the distal end of the guide wire protruding distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extending through the passageway in the control means.

42. A steerable catheter means comprising:

an outer flexible catheter member having distal and proximal ends,

an inner flexible catheter member having distal and proximal ends and two lumens extending therethrough, one of said lumens being closed at its distal end, the other lumen being open at its distal end, the inner catheter member extending through the outer catheter member, the distal end of the inner catheter member protruding distally beyond the distal end of the outer catheter member, and the inner catheter being movable within the outer catheter member,

a deflection wire having distal and proximal ends and extending the length of the inner catheter member through the lumen having the closed end, the distal end of the deflection wire being embedded in said closed end,

control means attached to the proximal end of the inner catheter member, the proximal end of the deflection wire extending to the control means and the control means having an engaging means which fixedly engages said deflection wire, rotation of said engaging means causing the deflection wire to longitudinally displace either toward or away from the distal end of the inner catheter member, said displacement causing the distal end of the inner catheter member to bend away from or toward the line of the longitudinal axis of the inner catheter member, the control means having a passageway in fluid communication with the open lumen, and the engaging means of the control means fixedly engaging the deflection wire so that when the control means is rotated, the inner catheter member and the steering wire both rotate substantially together to cause the distal end of the inner catheter member to rotate about its longitudinal axis, and

a balloon dilatation catheter extending through the open lumen, the balloon dilatation catheter having distal and proximal ends, the distal end of the balloon dilatation catheter having inflatable dilatation balloon means adjacent to said distal end and protruding distally beyond the distal end of the inner catheter member, and the proximal end of the balloon dilatation catheter extending through the passageway in the control means.

43. The catheter means of claim 42, wherein the balloon dilatation catheter has a guiding lumen therein, a guide wire having proximal and distal ends extends the length of the guiding lumen, the distal end of the balloon dilatation catheter protrudes distally beyond the distal end of the inner catheter member, and the proximal end of the guide wire extends proximally beyond the proximal end of the balloon dilatation catheter.